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Data / Medical devices / Germany / Dufner Instrumente GMBH

Dufner Instrumente GMBH: FDA-registered device maker in TUTTLINGEN Baden-Wurttemberg, Germany, 1 510(k) clearance

Dufner Instrumente GMBH is registered with the FDA (registration 9612278) in TUTTLINGEN Baden-Wurttemberg, Germany. It lists 104 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 5, 2001. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
9612278
FEI number
3002806862
Address
Foehrenstr. 9, TUTTLINGEN Baden-Wurttemberg, Germany, 78532
Owner or operator
DUFNER INSTRUMENTE GMBH (8010266)
Roles
Manufacturer
First device listed
November 15, 1993
Registered through
2026
Brand names listed
,MICRO, BELL, CIRCUMCISION, BLADE, SCALPEL, BONE CHISELS, BONE GOUGES, BOUGIE, UROLOGICAL, CLAMP, NON-ELECTRICAL, CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY and more

Devices it lists

DeviceProduct codeClassRoleSource
Applicator, Absorbent Tipped, Non-SterileKXF1Manufactureraccessdata.fda.gov
Bell, CircumcisionFHG2Manufactureraccessdata.fda.gov
Bit, DrillHTW1Manufactureraccessdata.fda.gov
Blade, Saw, General & Plastic Surgery, SurgicalGFA1Manufactureraccessdata.fda.gov
Blade, ScalpelGES1Manufactureraccessdata.fda.gov
Bougie, UrologicalFAX1Manufactureraccessdata.fda.gov
Carrier, LigatureGEJ1Manufactureraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Manufactureraccessdata.fda.gov
Chisel, Bone, SurgicalEML1Manufactureraccessdata.fda.gov
Chisel, Surgical, ManualFZO1Manufactureraccessdata.fda.gov
Clamp, Non-ElectricalFFN1Manufactureraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Manufactureraccessdata.fda.gov
Clamp, UterineHGC1Manufactureraccessdata.fda.gov
Contractor, SurgicalFZR1Manufactureraccessdata.fda.gov
Cover, Biopsy ForcepsFFF1Manufactureraccessdata.fda.gov
CuretteHTF1Manufactureraccessdata.fda.gov
Curette, OperativeEKE1Manufactureraccessdata.fda.gov
Curette, Surgical, General UseFZS1Manufactureraccessdata.fda.gov
Curette, UterineHCY1Manufactureraccessdata.fda.gov
Cutter, WireHXZ1Manufactureraccessdata.fda.gov
Depressor, Tongue, Non-SurgicalFMA1Manufactureraccessdata.fda.gov
Dilator, RectalFFP1Manufactureraccessdata.fda.gov
Dilator, TrachealKCG1Manufactureraccessdata.fda.gov
Dissector, Surgical, General & Plastic SurgeryGDI1Manufactureraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufactureraccessdata.fda.gov
Elevator, EntKAD1Manufactureraccessdata.fda.gov
Elevator, Surgical, General & Plastic SurgeryGEG1Manufactureraccessdata.fda.gov
ExtractorHWB1Manufactureraccessdata.fda.gov
File, Bone, SurgicalEMI1Manufactureraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Manufactureraccessdata.fda.gov
Forceps, Biopsy, Non-ElectricFCL1Manufactureraccessdata.fda.gov
Forceps, DisconnectFJR1Manufactureraccessdata.fda.gov
Forceps, EntKAE1Manufactureraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Manufactureraccessdata.fda.gov
Forceps, OphthalmicHNR1Manufactureraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Manufactureraccessdata.fda.gov
Forceps, Tube IntroductionBWB1Manufactureraccessdata.fda.gov
Forceps, Wire Closure, Ent, SterileJXX1Manufactureraccessdata.fda.gov
Forceps, Wire HoldingHYA1Manufactureraccessdata.fda.gov
Fork, TuningGWX1Manufactureraccessdata.fda.gov
Gag, MouthKBN1Manufactureraccessdata.fda.gov
Gouge, Surgical, General & Plastic SurgeryGDH1Manufactureraccessdata.fda.gov
Handle, ScalpelGDZ1Manufactureraccessdata.fda.gov
Holder, Needle, GastroenterologicFHQ1Manufactureraccessdata.fda.gov
Holder, Speculum, EntKAG1Manufactureraccessdata.fda.gov
Hook, Fibroid, GynecologicalHDE1Manufactureraccessdata.fda.gov
Hook, Gastro-UrologyFHB1Manufactureraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Manufactureraccessdata.fda.gov
Hook, Tonsil SuturingKBP1Manufactureraccessdata.fda.gov
Hook, TrachealKCH1Manufactureraccessdata.fda.gov
Instrument, Cast Application/Removal, ManualLGG1Manufactureraccessdata.fda.gov
Instrument, Cutting, OrthopedicHTZ1Manufactureraccessdata.fda.gov
Instrument, Ligature Passing And Knot TyingHCF1Manufactureraccessdata.fda.gov
Instrument, Surgical, Non-PoweredHAO1Manufactureraccessdata.fda.gov
Instruments, Surgical, CardiovascularDWS1Manufactureraccessdata.fda.gov
Knife, AmputationGDN1Manufactureraccessdata.fda.gov
Knife, OrthopedicHTS1Manufactureraccessdata.fda.gov
Knife, SurgicalEMF1Manufactureraccessdata.fda.gov
Laparoscope, General & Plastic SurgeryGCJ2Manufactureraccessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)HET2Manufactureraccessdata.fda.gov
MalletHXL1Manufactureraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Manufactureraccessdata.fda.gov
Mirror, EntKAI1Manufactureraccessdata.fda.gov
Mirror, Headband, OphthalmicHKF1Manufactureraccessdata.fda.gov
Mirror, MouthEAX1Manufactureraccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Manufactureraccessdata.fda.gov
Needle, Biopsy, CardiovascularDWO1Manufactureraccessdata.fda.gov
Needle, Neurosurgical SutureHAS1Manufactureraccessdata.fda.gov
Needle, Ophthalmic SuturingHNM1Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
OtoscopeERA1Manufactureraccessdata.fda.gov
Packer, UterineHDM1Manufactureraccessdata.fda.gov
Pin, Retentive And Splinting, And Accessory InstrumentsEBL1Manufactureraccessdata.fda.gov
ProbeHXB1Manufactureraccessdata.fda.gov
Probe, Rectal, Non-PoweredEXX1Manufactureraccessdata.fda.gov
RaspHTR1Manufactureraccessdata.fda.gov
Rasp, Surgical, General & Plastic SurgeryGAC1Manufactureraccessdata.fda.gov
Retention Device, SutureKGS1Manufactureraccessdata.fda.gov
RetractorGAD1Manufactureraccessdata.fda.gov
Retractor, All TypesEIG1Manufactureraccessdata.fda.gov
Retractor, VaginalHDL1Manufactureraccessdata.fda.gov
SawHSO1Manufactureraccessdata.fda.gov
Saw, Manual And AccessoriesGDR1Manufactureraccessdata.fda.gov
Scalpel, One-PieceGDX1Manufactureraccessdata.fda.gov
Scissors, EarJZB1Manufactureraccessdata.fda.gov
Scissors, EpisiotomyHDK1Manufactureraccessdata.fda.gov
Scissors, General, SurgicalLRW1Manufactureraccessdata.fda.gov
Scissors, NasalKBD1Manufactureraccessdata.fda.gov
Scissors, OphthalmicHNF1Manufactureraccessdata.fda.gov
Scissors, Orthopedic, SurgicalHRR1Manufactureraccessdata.fda.gov
Scissors, UmbilicalHDJ1Manufactureraccessdata.fda.gov
Scissors, Wire Cutting, Ent, SterileJYA1Manufactureraccessdata.fda.gov
ScoopFHL1Manufactureraccessdata.fda.gov
Sound, Urethral, Metal Or PlasticFBX1Manufactureraccessdata.fda.gov
Sound, UterineHHM1Manufactureraccessdata.fda.gov
Spatula, Surgical, General & Plastic SurgeryGAF1Manufactureraccessdata.fda.gov
Speculum, EntEPY1Manufactureraccessdata.fda.gov
Speculum, RectalFFQ1Manufactureraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Manufactureraccessdata.fda.gov
Stripper, Vein, ReusableGAI1Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
TrephineHWK1Manufactureraccessdata.fda.gov
Twister, WireHXS1Manufactureraccessdata.fda.gov
Unit, Suction OperatoryEBR1Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 5, 2001K002877MICTEC ENDOSCOPES AND ACCESSORIESGEISubstantially EquivalentDufner Instrumente GmbHaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
June 3, 202085894Class IITerminatedDUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injuryaccessdata.fda.gov

Compare with other makers

Updated February 5, 2001. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.